Director R&D

At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo! 🎯 🚀

We are looking for an enthusiastic Director, R&D to join our dynamic Strategic Scientific Affairs team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.

SUMMARY OF POSITION

The R&D Director will be responsible for the pharmaceutical development and tech transfer of new products, with a strong focus on the high-potent drugs in target finished dosage forms. Will perform duties in accordance with company policies and procedures. The R&D Director will work collaboratively within the R&D team, and other internal and external cross-functional teams to successfully drive the operational execution of R&D and TT products till approvals.

ORGANIZATION STRUCTURE

This role will report directly to the VP, R&D Global.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Hands on execution of the development programs and tech transfer of the new products - with a strong focus on the high-potent drugs, e.g., oncologic drugs, in target finished dosage forms.

• Together with the respective R&D team plan and elaborate on scientifically sound experimental development activities, and lead their execution, data interpretations and technical conclusions.

• Establish a strong relationship with key internal and external partners by regular technical meetings (remotely and face to face).

• Provide specification for API, Raw and packaging materials to support supply chain in the identification of suitable supplier.

• Facilitate the resolution of technical issues in a timely manner, driving action items and follow up.

• Manage and support DP validation activities.

• Create intellectual property covering pharmaceuticals products.

• Support internal and external functions to ensure a smooth transfer of technologies and products into additional commercial manufacturing site (if required).

• Ensure accurate tracking and reporting of project deliverables and milestones, maintaining consistent project documentation and preparing periodic updates for the Senior Management.

• Actively assist other department team members in reviewing documents on other projects (protocols, reports, regulatory filings, specifications, and the like).

• Establish effective working relationships within other key with internal and external cross-functional teams, e.g., PMO, RA, Intellectual Property, Production and Quality Assurance & Control.

QUALIFICATIONS & REQUIREMENTS

• BS/MS in Pharmacy or Pharmaceutical Technology with 8 years of industrial Drug Product development experience for highly regulated markets. PhD is an asset.

• Hands on experience and expertise in the pharmaceutical development of oral dosage forms and topicals. At least 3 years of experience on development with high-potent drugs is highly desirable.

• Experience with EMA, FDA, ANVISA and other regulated markets with understanding of regulatory requirements.

• Experience in management of high-performing R&D team.

• Able to demonstrate strong attention to detail while working under pressure.

• Ability to communicate and connect with all levels of the organization.

• Strong leadership and resource management skills.

• Excellent English written/oral communication skills are required.

CORE COMPETENCIES

• Business Focus

• Strategic Thinking

• Results & Operational Excellence

• Collaboration

• Quality

• Innovation & Continuous Improvement

• Change Agility

Why join us?

🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.

🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!